Fiorinal with Codeine

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Fiorinal with Codeine

INDICATIONS

Fiorinal with Codeine is
indicated for the relief of the symptom complex of tension (or muscle
contraction) headache.

Evidence supporting the
efficacy of Fiorinal with Codeine is derived from 2 multi-clinic trials that
compared patients with tension headache randomly assigned to 4 parallel
treatments: Fiorinal with Codeine, codeine, Fiorinal (Butalbital, Aspirin, and
Caffeine Capsules, USP), and placebo. Response was assessed over the course of
the first 4 hours of each of 2 distinct headaches, separated by at least 24
hours. Fiorinal with Codeine proved statistically significantly superior to
each of its components (Fiorinal, codeine) and to placebo on measures of pain
relief.

Evidence supporting the
efficacy and safety of Fiorinal with Codeine in the treatment of multiple recurrent
headaches is unavailable. Caution in this regard is required because codeine
and butalbital are habit-forming and potentially abusable.

DOSAGE AND ADMINISTRATION

One or 2 capsules every 4
hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of
this product is not recommended because of the potential for physical
dependence.